Gambro Renal Products, Incorporated

18 recalls •

• Categories: Other Medical Devices, Infusion Pumps

Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Infusion Pumps View Details →

Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box

Class I - Dangerous

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Jul 18, 2014 Other Medical Devices View Details →

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Class I - Dangerous

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Apr 16, 2014 Other Medical Devices View Details →

Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Class I - Dangerous

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Apr 16, 2014 Other Medical Devices View Details →

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

Class I - Dangerous

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Dec 9, 2013 Infusion Pumps Nationwide View Details →